510(k) K964782
K964782 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD CONTRAST HOLDER". The FDA issued a decision of Substantially Equivalent on February 25, 1997. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Medrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1997
- Date Received
- November 27, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stand, Infusion
- Device Class
- Class I
- Regulation Number
- 880.6990
- Review Panel
- HO
- Submission Type